Solid construct mitral spacer

ABSTRACT

A heart valve implant according to one embodiment may include a shaft extending generally along a longitudinal axis of the heart valve implant having at least one anchor configured to be coupled to a first end of the shaft. A spacer may include a plurality of individual segments each including at least one passageway configured to be disposed about the shaft. The plurality of individual segments may define an outer surface of the spacer which is configured to interact with at least a portion of at least one cusp of a heart valve to at least partially restrict a flow of blood through the heart valve in a closed position. The plurality of individual segments may each having a length and at least one cross-section dimension no larger than an internal cross-section of a lumen of a delivery catheter.

FIELD

The present disclosure relates to the repair and/or correction ofdysfunctional heart valves, and more particularly pertains to heartvalve implants and systems and methods for delivery and implementationof the same.

BACKGROUND

A human heart has four chambers, the left and right atrium and the leftand right ventricles. The chambers of the heart alternately expand andcontract to pump blood through the vessels of the body. The cycle of theheart includes the simultaneous contraction of the left and right atria,passing blood from the atria to the left and right ventricles. The leftand right ventricles then simultaneously contract forcing blood from theheart and through the vessels of the body. In addition to the fourchambers, the heart also includes a check valve at the upstream end ofeach chamber to ensure that blood flows in the correct direction throughthe body as the heart chambers expand and contract. These valves maybecome damaged, or otherwise fail to function properly, resulting intheir inability to properly close when the downstream chamber contracts.Failure of the valves to properly close may allow blood to flow backwardthrough the valve resulting in decreased blood flow and lower bloodpressure.

Mitral regurgitation is a common variety of heart valve dysfunction orinsufficiency. Mitral regurgitation occurs when the mitral valveseparating the left coronary atrium and the left ventricle fails toproperly close. As a result, upon contraction of the left ventricleblood may leak or flow from the left ventricle back into the leftatrium, rather than being forced through the aorta. Any disorder thatweakens or damages the mitral valve can prevent it from closingproperly, thereby causing leakage or regurgitation. Mitral regurgitationis considered to be chronic when the condition persists rather thanoccurring for only a short period of time.

Regardless of the cause, mitral regurgitation may result in a decreasein blood flow through the body (cardiac output). Correction of mitralregurgitation typically requires surgical intervention. Surgical valverepair or replacement is carried out as an open heart procedure. Therepair or replacement surgery may last in the range of about three tofive hours, and is carried out with the patient under generalanesthesia. The nature of the surgical procedure requires the patient tobe placed on a heart-lung machine. Because of theseverity/complexity/danger associated with open heart surgicalprocedures, corrective surgery for mitral regurgitation is typically notrecommended until the patient's ejection fraction drops below 60% and/orthe left ventricle is larger than 45 mm at rest.

BRIEF DESCRIPTION OF THE DRAWINGS

Features and advantage of the claimed subject matter will be apparentfrom the following description of embodiments consistent therewith,which description should be considered in conjunction with theaccompanying drawings, wherein:

FIG. 1 is a perspective view of an embodiment of a mitral valve implantconsistent with the present disclosure;

FIG. 2 depicts an embodiment mitral valve implant consistent with thepresent disclosure implanted within a heart in an open position;

FIG. 3 depicts an embodiment mitral valve implant consistent with thepresent disclosure implanted within a heart in a closed position;

FIG. 4 is a perspective view of the mitral valve implant shown in FIG. 1in an unassembled state consistent with the present disclosure;

FIG. 5 is an end view of one embodiment of the spacer segment consistentwith the mitral valve implant according to the present disclosure;

FIG. 6 is an end view of another embodiment of the spacer segmentconsistent with the mitral valve implant according to the presentdisclosure;

FIG. 7 is an end view of one embodiment of the spacer consistent withthe mitral valve implant according to the present disclosure;

FIG. 8 is a cross-sectional view of the spacer shown in FIG. 7 takenalong lines VIII-VIII;

FIG. 9 depict various arrangements of the spacer segments of a mitralvalve implant consistent with the present disclosure; and

FIG. 10 depicts one embodiment of an implant delivery system consistentwith the present disclosure.

DESCRIPTION

Referring to FIG. 1, a perspective view of one embodiment of a mitralvalve implant 10 is depicted. As shown, mitral valve implant 10 maygenerally include a spacer or valve body portion 12 which may be coupledto a shaft 14. The shaft 14 may be coupled to at least one anchorportion 16 configured to couple, attach, and/or otherwise secure themitral valve implant 10 to native coronary tissue. In general, at leasta portion of the spacer 12 may be configured to be disposed proximate amitral valve such that the mitral valve implant 10 may interact and/orcooperate with at least a portion of the native mitral valve to reduceand/or eliminate excessive regurgitation as illustrated in FIGS. 2 and3.

The spacer 12 of the mitral valve implant 10 shown in FIG. 1 may includea plurality of individual segment 20 a-20 n. As will be explained ingreater detail hereinbelow, the plurality of segments 20 a-20 n may beconfigured to be delivered and assembled proximate an implant site ofthe mitral valve implant 10 to form a spacer 12 having an overall sizeand shape configured to accommodate, at least in part, a patient'sanatomy, etiology of valve regurgitation, and/or the limitations of theimplant delivery system. Each of the plurality of segments 20 a-20 n maybe configured to have a size and shape such that at least one dimensionof the segment 20 a-20 n is no larger than at least one internaldimension of the implant delivery system used to deliver the mitralvalve implant 10 to the implant site. As such, a mitral valve implant 10may be constructed having a spacer 12 with at least one cross-sectionaldimension that is larger than the internal cross-sectional dimensions ofthe implant delivery system used to deliver the mitral valve implant 10.

According to one aspect, the mitral valve implant 10 and the spacer 12is shown in an unassembled/partially assembled state in FIG. 4. Theplurality of segments 20 a-20 n may be slidably coupled over at least aportion of the shaft 14. For example, the plurality of segments 20 a-20n may each include at least one passageway 22 configured to accept atleast a portion of the shaft 14. As illustrated, one or more of thepassageways 22 may define a generally cylindrical opening or passagewayhaving an internal dimension (e.g., an internal radius) substantiallycorresponding to the outer radius of a generally cylindrical shaft 14.The internal dimension of the passageway 22 may sufficiently greaterthan the outer radius of the shaft 14 such that the plurality ofsegments 20 a-20 n may move along a non-linear shaft 14. In other words,the internal radius of the passageway 22 may be large enough such thatthe plurality of segments 20 a-20 n may move along the longitudinallength of a non-linear or curved shaft 14. The passageways 22 may beconfigured to generally extend completely around the circumference ofthe shaft 14 and/or may be configured to generally extend only around aportion of the circumference of the shaft 14.

Those skilled in the art will recognize that the passageways 22 and/orthe shaft 14 may have a shape other than a cylinder. For example, thepassageways 22 and/or the shaft 14 may have a non-circular cross-sectionsuch as, but not limited to, an oval or elliptical cross-section or thelike. For example, the passageways 22 and/or the shaft 14 may form alock-and-key type arrangement configured to prevent the segments 20 a-20n from rotating about radial direction of the shaft 14.

Referring to FIG. 5, a cross-section of segment 22 n of FIG. 4 is shown.The body 24 of segment 22 n may include an outer surface 26 which maydefine at least a portion of the outer surface 27 (FIG. 1) of the spacer12 when assembled and at least one cross-sectional surface 28. Accordingto one aspect, the body 24 may have a generally circular sector orpie-piece cross-section. The passageway 22 may be formed as a separatecomponent from the body 24 and may be coupled, attached, molded, bondedor otherwise secured to the body 24 of the segment 22 n. The passageway22 may also be formed as an integral, unitary, and/or single componentwith the body 24. According to one aspect, the passageway 22 may bedisposed proximate a centerline of the spacer 12. For example, thepassageway 22 may be disposed proximate an intersection between thefirst and the second cross-sectional surfaces 28 a, 28 b. The passageway22 may also be disposed within an internal region of the body 24 asshown in FIG. 6.

As mentioned above, the plurality of segments 20 a-20 n may beconstructed to form a spacer 12, FIG. 7, having an outer surfaceconfigured to, at least in part, accommodate a patient's anatomy,etiology of valve regurgitation, and the limitations of the implantdelivery system. A cross-sectional view of the assembled spacer 12 inFIG. 7 is illustrated in FIG. 8. According to one aspect, thepassageways 22 a-22 n of each of the plurality of segments 20 a-2 n maybe aligned serially along the longitudinal axis of the spacer 12. Forexample, each of the passageways 22 a-22 n, FIGS. 9 a-9 d, may be spacedalong the longitudinal axis of each of the plurality of segments 20 a-20n. According to this aspect, the passageways 22 a-22 n do not overlapeach other when the plurality of segments 20 a-20 n are assembled asshown in FIG. 8. The passageways 22 a-22 n may be evenly spaced alongthe longitudinal axis of the plurality of segments 20 a-20 n such thateach passageway 22 a-22 n substantially abuts against at least oneadjacent passageway 22 a-22 n. Such an arrangement aids in theconstruction of the spacer 12 since the plurality of segments 20 a-20 nmay only fit together in a single configuration. The passageways 22 a-22n may also be unevenly spaced along the plurality of segments 20 a-20 nand/or may at least partially overlap each other. Those skilled in theart will recognize that a variety of geometries and configurations existdepending on the desired overall size and shape of the spacer 12 as wellas the dimensional limitations of the implant delivery system.

According to one aspect, at least a portion of the body 24 of one ormore of the plurality of segments 20 a-20 n may be expandable,retractable, collapsible and/or reducible in volume to facilitatepercutaneous and/or transluminal delivery of the mitral valve implant10. In such a manner, one or more of the segments 20 a-20 n of themitral valve implant 10 may include a collapsible member, which may bereduced in volume and/or reduced in maximum cross-section duringdelivery to the heart and/or during placement and/or attachment of theanchor 16 to native coronary tissue. After delivery to the heart, thesegments 20 a-20 n may be expanded, inflated, and/or otherwise increasedin volume or size. Accordingly, the mitral valve implant 10 may bedelivered to an implantation site via a smaller diameter catheter,and/or via smaller vessels, than would otherwise be required.

The deformable segments 20 a-20 n may be collapsed to a reduced size,which may, for example, facilitate loading the mitral valve implant 10into a catheter delivery system. Such a catheter delivery system may besuitable for transluminal delivery of a mitral valve implant 10,including the segments 20 a-20 n, to the heart as will be explainedfurther below. In addition to being collapsed, the segments 20 a-20 nmay be deformed to facilitate loading into a catheter delivery system.For example, the segments 20 a-20 n may be collapsed and may be rolledand/or folded to a generally cylindrical shape, allowing the segments 20a-20 n to be loaded in a catheter having a circular lumen.

A collapsed and/or rolled or folded segments 20 a-20 n may be inflated,restoring the segments 20 a-20 n to expanded configuration. For example,a collapsed and/or rolled or folded segments 20 a-20 n may be inflatedand restored to an expanded configuration once the mitral valve implant10 has been delivered to the heart and deployed from a catheter deliverysystem. Inflating the segments 20 a-20 n may be carried out byintroducing a fluid, such as saline, into the at least one cavity of thesegments 20 a-20 n. In addition to a liquid, such as saline, thesegments 20 a-20 n may be inflated with a setting or curable fluid. Thesetting or curable fluid may set and/or be cured to a solid and/orsemi-solid state within the cavity of the segments 20 a-20 n. An exampleof such a material may be a thermoset polymer resin, a gel material,such as silicone gel, etc.

At least a portion of the segments 20 a-20 n may also be constructedfrom a shape-memory material. For example, at least a portion of thesegments 20 a-20 n may include a shape-memory alloy such as, but notlimited to, copper-zinc-aluminum, copper-aluminum-nickel, andnickel-titanium (NiTi) alloys. The shape-memory alloy may include eitherone-way or two-way shape memory and may be introduced in to the deliverycatheter lumen having a shape which does not exceed the interiordimensions of the delivery catheter lumen. For example, the segments 20a-20 n may have a generally elongated or generally helical shape. Upondelivery to proximate the mitral valve, the shape-memory segments 20a-20 n may be heated to cause the segments 20 a-20 n to deform into thedesired shape for installation.

Alternatively (or in addition), one or more of the plurality of segments20 a-20 n may have generally solid geometry. As used herein, the phrases“generally solid geometry,” “substantially solid geometry,” or the likeare intended to mean a geometry having an outer surface that defines asubstantially fixed or constant volume. That is, a volume of thesegments 20 a-20 n does not substantially change before and afterimplantation of the mitral valve implant 10. A “generally solidgeometry” may include, without limitation, a solid, semi-solid, orporous (e.g., micro- or nano-scale pores) material. The use a pluralityof segments 20 a-20 n having a generally solid geometry may reduce thecomplexity and/or cost associated with the fabrication and/orimplantation of the mitral valve implant 10 while still allowing amitral valve implant 10 with a spacer 12 that is at least as large as,or optionally larger than, the implant delivery system used to deliverthe mitral valve implant 10.

At least a portion of the plurality of segments 20 a-20 n may beconstructed from a synthetic and/or biological material depending on theapplication and the patient condition. The segments 20 a-20 n mayinclude a plurality of layers. For example, the segments 20 a-20 n mayinclude an open or closed cell foam substrate (for example, but notlimited to, Invalon polyvinyl) and an outer layer of a material that isbiologically acceptable. The outer layer may also include a materialthat is soft and/or deformable (either permanently or resilientlydeformable) that may reduce and/or eliminate further scarring and/ordamage to the leaflets 19 of the mitral valve 18. According to oneaspect, the substrate of the segments 20 a-20 n may be coated with asilicone urethane composite such as, but not limited to, Elasteon or thelike.

The plurality of segments 20 a-20 n, when assembled, may form a spacer12 having an outer surface 27 that may be configured to interact and/orcooperate with at least a portion of the native mitral valve 18 (e.g.,the leaflets 19) to reduce and/or eliminate excessive regurgitation asillustrated in FIGS. 2 and 3. According to one aspect, the mitral valveimplant 10 (and in particular, the spacer 12) may be selected from arange or set of sizes and shapes. For example, a “standard set” may beutilized where a set of “consensus” sizes and shapes mitral valveimplants 10 are pre-manufactured and provided to health care providersas a kit. This particular aspect has the advantage of being the mostuniform and therefore the least expensive for the patient.Alternatively, a “custom design” may be fabricated where the exact sizeand shape is determined only after precise and/or detailed measurementsof the dimensions of a patient's mitral valve 18 are obtained. As aresult, the overall size and/or shape of the mitral valve implant 10 maybe tapered or shaped if necessary.

In practice, the plurality of segments 20 a-20 n may be aligned seriallyalong at least a portion of the shaft 14 (i.e., one segment 20 a afteranother segment 20 b) and inserted into the implant delivery system 100,a portion of which is generally depicted in FIG. 10. The implantdelivery system 100 may include a catheter 101 having a generallycircular inner passageway 104. Those skilled in the art will recognizethat the catheter 101 may include any catheter known to those skilled inart. While only a single passageway 104 is shown for clarity, thecatheter 101 may include a plurality of passageways 104. According toone aspect, the plurality of segments 20 a-20 n may be rotated about theshaft 14 such that each of the plurality of segments 20 a-20 n isaligned in a substantially similar or substantially the same orientationwith respect to each other. As such, overall cross-sectional dimensionsof the mitral valve implant 10 may be minimized. Additionally, themitral valve implant 10 may be inserted into a catheter 101 having areduced diameter.

Once loaded into the delivery catheter system 100, the mitral valveimplant 10 may be moved or delivered proximate the implant site usingany device know to those skilled in the art. While moving the mitralvalve implant 10 through the delivery catheter system 100, the pluralityof segments 20 a-20 n may be individually rotated about the shaft 14 tofacilitate movement of the plurality of segments 20 a-20 n. This may beparticularly useful to facilitate navigating the plurality of segments20 a-20 n about curves, bends or the like 106. The shaft 14 may includea generally rigid shaft and/or a generally flexible shaft.

According to another aspect, shaft 14 and the plurality of segments 20a-20 n may be separately loaded into the catheter delivery system 100and delivered to the implant site. According to this aspect, the shaft14 (which may optionally include the anchor portion 16) may be firstloaded into the catheter delivery system and the plurality of segments20 a-20 n may be subsequently serially loaded into the catheter deliverysystem 100. Of course, the order of loading and/or delivering the shaft14 and/or plurality of segments 20 a-20 to the implant site may bechanged.

Once the shaft 14 and the plurality of segments 20 a-20 n are proximatethe implant site, the plurality of segments 20 a-20 n may be disposed orarranged about the shaft 14 to construct a spacer 12 having a desiredsize and shape. While the spacer 12 is illustrated having a generallycylindrical outer surface, the size and shape of the spacer 12 and eachof the plurality of segments 20 a-20 n may be varied by design and byquantity to accommodate the patient anatomy, etiology, and limitationsof the delivery system 100 (e.g., the internal dimensions of thecatheter lumen).

According to an embodiment, the spacer 12, FIG. 1, may be slidablycoupled to the shaft 14. The spacer 12 may include an opening 46 (whichmay be defined by one or more of the passageways 22 a-n) extending froma first end 44 of the spacer 12, through the spacer 12, and to a secondend 40. In one such embodiment, the opening 46 may extend generallyaxially through the spacer 12 and may be sized to slidably receive atleast a portion of the shaft 14 therethrough. The shaft 14 may includeone or more stops 48, 50. The stops 48, 50 may be sized and/or shaped tocontrol and/or restrict translation of the spacer 12 along the shaft 14beyond the respective stops 48, 50. In this manner, in the illustratedembodiment, translation of the spacer 12 along the shaft 14 may berestricted to the expanse of the shaft 14 between the stops 48, 50.

One or more of the stops 48, 50 may be integrally formed with the shaft14. Furthermore, one or more of the stops 48, 50 (such as, but notlimited to, stop 50) may be provided as a separate member coupled toand/or formed on the shaft 14. In an embodiment in which one or more ofthe stops 48, 50 are integrally formed with the shaft 14, the spacer 12may be slidably coupled to the shaft 14 by pressing the spacer 12 overat least one of the stops 48, 50, which may at least partiallyelastically deform the opening 46 to permit passage of at least one ofthe stops 48, 50. Once the one or more of the stops 48, 50 have beenpressed through the opening 46, the opening 46 may at least partiallyelastically recover, thereby resisting passage of the one or more stops48, 50 back through the opening 46. Various other arrangements may beemployed for providing stops on the shaft 14 and/or for controllingand/or limiting translation of the spacer 12 along the shaft 14.

The anchor portion 16 may include a helical member 52 coupled to theshaft 14. As shown, the helical member 52 may be loosely wound such thatadjacent turns of the helical member 52 do not contact one another, forexample resembling a corkscrew-type configuration. The anchor portion 16may be engaged with tissue by rotating the anchor portion 16 about theaxis of the helical member 52, thereby advancing the anchor portion 16into tissue. Consistent with such an embodiment, the anchor portion 16may resist pulling out from the tissue. The anchor portion 16 may beprovided as an extension of the shaft 14 wound in a helicalconfiguration. Consistent with related embodiments, the anchor portion16 may be formed as a separate feature and may be coupled to the shaft14, e.g., using mechanical fasteners, welding, adhesive, etc.

According to various alternative embodiments, the anchor portion 16 mayinclude various configurations capable of being coupled to and/orotherwise attached to native coronary tissue. For example, the anchorportion 16 may include one or more prongs adapted to pierce coronarytissue and to alone, or in conjunction with other features, resistremoval of the anchor portion 16 from tissue. For example, the anchorportion 16 may include a plurality of prongs which may engage nativecoronary tissue. According to various other embodiments, the anchorportion 16 may include features that may facilitate attachment bysuturing. Exemplary features to facilitate suturing may include rings oropenings, suture penetrable tabs, etc. Various other anchor portions 16that may allow attachment or coupling to native coronary tissue may alsosuitably be employed in connection with the present disclosure.

Turning to FIGS. 2 and 3, the mitral valve implant 10 is shown implantedwithin a heart 102. The mitral valve implant 10 may be disposed at leastpartially within the left ventricle 64 of the heart 102. As shown, theanchor portion 16 may be engaged with native coronary tissue withinand/or adjacent to the left ventricle 64. The shaft 14, coupled to theanchor portion 16, may extend into the left ventricle 64. The shaft 14may further extend at least partially within the mitral valve 18, i.e.,the shaft 14 may extend at least partially between the cusps or leaflets19 of the mitral valve 18, and may also extend at least partially intothe left atrium 62. The spacer 12 of the mitral valve implant 10 may bepositioned at least partially within the left ventricle 64 with thebottom portion 44 within the left ventricle 64 and with the upperportion 40 positioned at least partially within and/or pointed towardsthe left atrium 62.

FIG. 2 depicts the heart 102 in a condition in which the pressure ofblood within the left atrium 62 is at equal to, or higher than, thepressure of blood within the left ventricle 64, e.g., during contractionof the left atrium 62. As shown, when the pressure of blood within theleft atrium 62 is greater than or equal to the pressure of blood withinthe left ventricle 64, blood may flow from the left atrium 62 into theleft ventricle 64. The pressure differential and/or the flow of bloodfrom the left atrium 62 to the left ventricle 64 may slidably translatethe spacer 12 along the shaft 14 toward the left ventricle 64, in thedirection of blood flow between the chambers.

Sliding translation of the spacer 12 along the shaft 14 may at leastpartially withdraw the spacer 12 from the mitral valve 18 to an openposition, as shown. When the spacer 12 is at least partially withdrawnfrom the mitral valve 18, a passage may be opened between the spacer 12and the mitral valve 18, allowing blood to flow from the left atrium 62to the left ventricle 64. Translation of the spacer 12 away from themitral valve 18 may be controlled and/or limited by the stop 48. In theopen position, the stop 48 may maintain the spacer 12 in generalproximity to the mitral valve 18 while still permitting sufficientclearance between the mitral valve 18 and the spacer 12 to permitadequate blood flow from the left atrium 62 to the left ventricle 64.Additionally, the flow of blood from left atrium 62 to the leftventricle 64 may cause the mitral valve 18 to flare and/or expandoutwardly away from the mitral valve implant 10, permitting blood flowbetween the implant 10 and the cusps 19 of the mitral valve 19.

As the left ventricle 64 contracts, the pressure of blood in the leftventricle 64 may increase such that the blood pressure in the leftventricle 64 is greater than the blood pressure in the left atrium 62.Additionally, as the pressure of the blood in the left ventricle 64initially increases above the pressure of the blood in the left atrium62, blood may begin to flow towards and/or back into the left atrium 62.The pressure differential and/or initial flow of blood from the leftventricle 64 into the left atrium 62 may act against the spacer 12 andmay translate the spacer 12 toward the left atrium 104. For example,pressurized blood within the left ventricle 64 may act against thebottom 24 of the spacer 12 inducing sliding translation of the spacer 12along the shaft 14 toward the left atrium 62.

In the closed position as shown in FIG. 3, the spacer 12 may betranslated toward and/or at least partially into the left atrium 62. Atleast a portion of the spacer 12 may interact with, engage, and/or bepositioned adjacent to at least a portion of the mitral valve 18. Forexample, at least a portion of at least one cusp 19 of the mitral valve18 may contact at least a portion of the spacer 12. Engagement betweenthe spacer 12 and the mitral valve 18 may restrict and/or prevent theflow of blood from the left ventricle 64 back into the left atrium 62.

In addition to the translation of the spacer 12, the mitral valve 18 mayalso at least partially close around the spacer 12, thereby alsorestricting and/or preventing the flow of blood from the left ventricle64 to the left atrium 62. For example, as mentioned above, at least aportion of one or both of the cusps 19 of the mitral valve 18 maycontact at least a portion of the spacer 12. In some embodiments, as thepressure of the blood in the left ventricle 64 increases, the pressureagainst the bottom 44 of the spacer 12 may increase. The increase inpressure against the bottom 44 of the spacer 12 may, in turn, increasethe engagement between the spacer 12 and the mitral valve 18.

Sliding translation of the spacer 12 toward the left atrium 62 may atleast partially be controlled and/or limited by the stop 50 coupled tothe shaft 14. Additionally, translation of the spacer 12 toward the leftatrium 62 may be at least partially limited and/or controlled byengagement between the spacer 12 and the mitral valve 18. One or both ofthese restrictions on the translation of the spacer 12 may, in someembodiments, prevent the spacer 12 from passing fully into the leftatrium 62. Furthermore, the diameter and/or shape of the spacer 12 maylimit and/or restrict the movement of the spacer 12 into the left atrium62.

The preceding embodiment may, therefore, provide a mitral valve implantthat is slidably translatable relative to the mitral valve to reduceand/or eliminate regurgitation. Additional embodiments of a mitral valveimplant are described in co-pending U.S. patent application Ser. No.11/258,828, entitled “Heart Valve Implant” filed on Oct. 26, 2005, whichis fully incorporated herein by reference. For example, the mitral valveimplant may include a generally stationary spacer and may include morethan one anchoring portions.

The implant herein has been disclosed above in the context of a mitralvalve implant. An implant consistent with the present disclosure mayalso suitably be employed in other applications, e.g., as an implantassociated with one of the other valves of the heart, etc. The presentinvention should not, therefore, be construed as being limited to usefor reducing and/or preventing regurgitation of the mitral valve.

According to one aspect, the present disclosure features a heart valveimplant. The heart valve implant may include a shaft extending generallyalong a longitudinal axis of the heart valve implant. A spacer maycomprise a plurality of individual segments each including at least onepassageway configured to be disposed about the shaft. The plurality ofindividual segments may define an outer surface of the spacer configuredto interact with at least a portion of at least one cusp of a heartvalve to at least partially restrict a flow of blood through the heartvalve in a closed position. The heart valve implant may also include atleast one anchor configured to be coupled to a first end region of theshaft.

According to another aspect, the present disclosure features a method ofintroducing a heart valve implant with respect to a heart valve. Themethod may include providing a heart valve implant comprising a shaft, aspacer including a plurality of individual segments each including atleast one passageway configured to be disposed about the shaft, and atleast one anchor configured to be coupled to the shaft. The plurality ofindividual segments may be serially aligned. The aligned plurality ofindividual segments and the shaft may be percutaneously deliveredproximate the heart. The plurality of individual segments may bearranged about shaft to define the spacer wherein the plurality ofindividual segments define an outer surface of the spacer configured tointeract with at least a portion of at least one cusp of the heart valveto at least partially restrict a flow of blood through the heart valvein a closed position. The heart valve implant may also be secured withinthe heart.

According to yet another aspect, the present disclosure features a heartvalve implant system. The heart valve system may include a catheterincluding a lumen and a heart valve implant. The heart valve implant maycomprise a shaft extending generally along a longitudinal axis of theheart valve implant. A spacer may include a plurality of individualsegments each having a length and at least one cross-section dimensionno larger than an internal cross-section of the lumen. The plurality ofindividual segments may be configured to be disposed about at least aportion of the shaft to define an outer surface of the spacer configuredto interact with at least a portion of at least one cusp of a heartvalve to at least partially restrict a flow of blood through the heartvalve in a closed position. At least one anchor may be configured to becoupled to a first end region of the shaft.

As mentioned above, the present disclosure is not intended to be limitedto a system or method which must satisfy one or more of any stated orimplied object or feature of the present disclosure and should not belimited to the preferred, exemplary, or primary embodiment(s) describedherein. The foregoing description of a preferred embodiment of thepresent disclosure has been presented for purposes of illustration anddescription. It is not intended to be exhaustive or to limit the presentdisclosure to the precise form disclosed. Obvious modifications orvariations are possible in light of the above teachings. The embodimentwas chosen and described to provide the best illustration of theprinciples of the present disclosure and its practical application tothereby enable one of ordinary skill in the art to utilize the presentdisclosure in various embodiments and with various modifications as issuited to the particular use contemplated. All such modifications andvariations are within the scope of the present disclosure as determinedby the claims when interpreted in accordance with breadth to which theyare fairly, legally and equitably entitled.

What is claimed is:
 1. A heart valve implant comprising: a shaftextending generally along a longitudinal axis of said heart valveimplant; a spacer comprising a plurality of individual segments eachincluding at least one passageway configured to be slidably advancedover said shaft, wherein said plurality of individual segments define anouter surface of said spacer configured to interact with at least aportion of at least one cusp of a heart valve to at least partiallyrestrict a flow of blood through said heart valve in a closed position,wherein at least one of said plurality of individual segments includes abody portion having a generally circular sector cross-section; and atleast one anchor configured to be coupled to a first end region of saidshaft, said at least one anchor is selected from the group consisting ofa screw, a prong, and a suture.
 2. A heart valve implant according toclaim 1, wherein each of said plurality of individual segments definesat least a portion of said outer surface of said spacer when saidplurality of individual segments are assembled about said shaft.
 3. Aheart valve implant according to claim 1, wherein at least one of saidplurality of individual segments includes a body portion having agenerally circular sector cross-section and wherein said at least onepassageway is disposed proximate a centerline of said spacer along alongitudinal axis of said at least one segment.
 4. A heart valve implantaccording to claim 1, wherein at least one of said plurality ofindividual segments includes a body portion having a generally circularsector cross-section and wherein said at least one passageway isdisposed through said body portion.
 5. A heart valve implant accordingto claim 1, wherein each of said plurality of individual segmentsincludes a single passageway, wherein each of said passageways areevenly spaced along a longitudinal axis of said plurality of individualsegments.
 6. A heart valve implant according to claim 1 wherein saidplurality of individual segments are configured to move along saidlongitudinal axis of said shaft.
 7. A heart valve implant according toclaim 6, wherein at least one of said passageways is configured torotate about a radial axis of said shaft.
 8. A heart valve implantaccording to 6 wherein said at least one of said passageways includes aninternal cross-section configured to allow said segment to move along anon-linear portion of said longitudinal axis of said shaft.
 9. A heartvalve implant according to claim 6, wherein said at least one of saidpassageways is configured to be substantially non-rotatable about aradial axis of said shaft.
 10. A heart valve implant system comprising:a catheter including a lumen; and a heart valve implant comprising: ashaft; a spacer comprising a plurality of individual segments eachhaving a length and at least one cross-section dimension no larger thanan internal cross-section of said lumen, wherein said plurality ofindividual segments are configured to be slidably advanced over at leasta portion of said shaft to define an outer surface of said spacerconfigured to interact with at least a portion of at least one cusp of aheart valve to at least partially restrict a flow of blood through saidheart valve in a closed position, wherein at least one of said pluralityof individual segments includes a body portion having a generallycircular sector cross-section; and at least one anchor configured to becoupled to a first end region of said shaft, said at least one anchor isselected from the group consisting of a screw, a prong, and a suture.11. A heart valve implant system according to claim 10, wherein saidplurality of individual segments each include a body portion having agenerally circular sector cross-section having a radius which is nolarger than an internal diameter of said lumen.
 12. A heart valveimplant system according to claim 10, wherein said spacer includes atleast one cross-sectional dimension which is larger than said internalcross-section of said lumen.